Grant Number:	1R01CA275055-01A1 Interpret this number
Primary Investigator:	Winters-Stone, Kerri
Organization:	Oregon Health & Science University
Project Title:	Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (ILIVE)
Fiscal Year:	2023

Over 1 million men in the U.S. are receiving androgen deprivation therapy (ADT) to prevent prostate cancer progression. Although a critical therapeutic strategy, ADT increases the risk of frailty, weight gain and obesity in prostate cancer survivors (PCS). In our recent study, the odds of PCS having both obesity plus frailty, i.e., obese frailty, were 19x higher in ADT users compared to non-users and obese frailty was a significant and stronger predictor of recurrent falls than frailty alone. Thus, interventions are urgently needed to mitigate the obese frailty in PCS that threatens independence and quality of life and which multiplies health care costs. However, there are currently no effective interventions in clinical practice for PCS that target obese frailty as a clinical endpoint. Given that the number of PCS on ADT is growing by over 30,000 each year, there is a critical need to develop scalable interventions with high reach potential to address this urgent practice gap and rising public health issue. The co-principal investigators for this application each have strong prior work demonstrating efficacy for reducing obesity via online dietary intervention and frailty via online supervised resistance training, respectively. The urgent need to address obese frailty in PCS on ADT now supports combining these interventions into a single, scalable online program. To advance this work toward clinical practice, our strong multidisciplinary team of experts in nutrition, exercise science, urology, oncology, behavioral theory, health economics, and implementation science, proposes a 2-arm parallel group randomized Type I hybrid effectiveness-implementation trial focused on obese frailty in PCS on ADT. This design allows formal testing of the effectiveness of a combined online, self-directed weight loss + group-based resistance training program (Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors: iLIVE) against usual care with obese frailty as a primary endpoint. Our Primary Aim is to compare iLIVE to UC on obese frailty in 250 PCS on ADT over a 6-month period. Secondary Aims are to: a) Compare the effect of iLIVE to UC on secondary outcomes, e.g., individual frailty criterion, dietary quality, physical function, quality of life; b) Assess the durability of iLIVE to UC by comparing groups at 12-month follow-up; and c) Explore potential moderators (e.g., age, race, BMI) associated with intervention effectiveness. Finally, our Tertiary Aim is to: Assess key implementation outcomes (e.g., cost, acceptability) to guide future research regarding the implementation of iLIVE into the clinical care pathway. iLIVE builds on a solid foundation of diet and exercise interventions in cancer survivors with proven efficacy, and the proposed Type I hybrid effectiveness-implementation trial is designed to speed effectiveness testing and optimization and ultimately enable reductions in morbidity and mortality for over 1 million older PCS across the nation.





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